BEUDAMED
    18 results · 32ms · Sources: EU EUDAMED, US FDA

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    ONEUSE- PLUS MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HairCheck-DT (THC)

    FDA UDI
    Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...

    ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MICROMATRIX

    FDA Adverse Event
    Malfunction ·ACELL, INC.·Product code KGN·September 17, 2024

    FOLEY CATHETER, 16 FR, 5CC

    FDA Adverse Event
    Injury ·SITE-8040297 EUROMEDICAL·Product code KOD·February 12, 1997

    MICROMATRIX, 500 MG

    FDA Adverse Event
    Malfunction ·INTEGRA - ACELL(COLUMBIA)·Product code KGN·October 4, 2024

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 3, 2013

    DIAGNOST 96 MCP/SCP-DSI

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code JAA·February 15, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·May 7, 2008

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 8 MML X 3.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 19, 2020

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 10, 2023

    INCLUSIVE TAPERED IMPLANT 3.2 MMD X 13 MML X 3.0 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 19, 2020

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 8 MML X 3.5 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 6, 2018

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018